Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited reported human patch test with large number of fragrances and their ingredients tested on 26 workers, no individual data

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Study type:
health record from industry
Endpoint addressed:
skin sensitisation
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
5% the test substance in petrolatum patch tested according to the standard series following the ICDRG guidelines. The application time on the back was 2 days. The readings were taken on the Day 3 and Day 4.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzaldehyde
EC Number:
202-860-4
EC Name:
Benzaldehyde
Cas Number:
100-52-7
Molecular formula:
C7H6O
IUPAC Name:
benzaldehyde
Details on test material:
No data given

Method

Type of population:
occupational
Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
To find out the causes of increasing number of skin diseases, first of all we carried out a site inspection at the factory (working condition, working process, work places), then a dermatological health survey of all 26 workers was accomplished. 5% the test substance in petrolatum patch tested according to the standard series following the ICDRG guidelines. The application time on the back was 2 days. The readings were taken on the D3 and D4. The concentrations were chosen because of the advice by Fisher.

Results and discussion

Results:
9 positive reactions from the test substance were recorded in 18 out of 26 persons with 3 fragrance allergy reactions in the 6 eczema patients.

Applicant's summary and conclusion

Conclusions:
The test substance was one of the main causes of allergic contact dermatitis and positive patch test reactions.
Executive summary:

5% the test substance in petrolatum patch tested according to the standard series following the ICDRG guidelines. The application time on the back was 2 days. The readings were taken on the Day 3 and Day 4.

The test substance was one of the main causes of allergic contact dermatitis and positive patch test reactions.